Maree Zinzley, Manager Approvals of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following variation application has been made to a registered trade name product under section 9(2) of the Act:
Trade Name: Kelaprofen 10%
Reference: A009851 – 8
Active Ingredient and Concentration:
Formulation Type: Aqueous solution
General Use Claim:
Horses: Anti-inflammatory and analgesic treatment of musculoskeletal disorders, including: lameness of traumatic origin,arthrosis, arthritis, osteitis, spavin, navicular disease, tendonitis, bursitis, laminitis, myositis, post-surgical inflammation.Symptomatic analgesic treatment in colic, alone or associated with causal therapy.Symptomatic treatment of fever. Cattle: anti-inflammatory, analgesic and antipyretic treatment of respiratory disorders, acute mastitis, mammary oedema, colic, and musculoskeletal disorders.
Proposed New Claim:
Proposed new meat withholding period following intramuscular administration of 2 days.
Any person may make a written submission to the director-general concerning this application.
Under sections 16 and 17 of the Act, a written submission:
- must state in full the reasons for making the submission;
- may state any decision sought on that application; and
- must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.
Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.
The following address is:
- where submissions on this application are to be sent;
- where requests for copies of the public information relating to the application can be sent;
- where public information relating to the application can be viewed; and
- the director-general’s address for service:
ACVM Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Kela N.V., Sint Lenaartseweg 48, 2320 Hoogstraten, Belgium. Postal Address: Phoenix Pharm Distributors Ltd., PO Box 31363, Milford, Auckland.
Dated at Wellington this 16th day of July 2021.
MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).